Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

NCT02439034 | Completed Phase 2

• 2 other identifiers: KETOCOL-13042013-005510-35
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

Conditions

Uterine Cervical Cancer; Upper Aerodigestive Tract Neoplasms

Keywords

pain management; brachytherapy

Outcome Measures

Primary Outcomes (1)

• Level of immediate post-operative pain

  Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is \< 4, 4 hours after the surgical operation.

  Day 1

Secondary Outcomes (3)

• Level of pain linked to the operative procedure during brachytherapy and at home

  Day 1 (8, 12 hours), Days 3, 15 and 30

• Tolerance of the analgesic treatment

  30 days

• Assessment of anxiety

  inclusion, Days 3 and 30

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Paracetamol

Drug: Paracetamol

Arm B

EXPERIMENTAL

Paracetamol + Ketoprofen

Drug: Paracetamol; Drug: Ketoprofen

Interventions

Paracetamol DRUG

Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)

Also known as: PARACETAMOL B BRAUN, PARACETAMOL CODEINE ARROW, Acetaminophen

Arm A; Arm B

Ketoprofen DRUG

Ketoprofen\* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.

Also known as: BI PROFENID LP, PROFENID

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a uterine cervical cancer or an upper aero-digestive tract cancer
• Age ≥ 18 years and ≤ 75 years
• Patient who are eligible for brachytherapy treatment associated with or without hospital stay
• With operative procedure under general anesthesia to set up the material needed for brachytherapy
• Performance status ≤ 2
• Creatinine Clearance ≥ 60 ml/min using Cockcroft equation
• No coagulation disorder or anticoagulation therapy at curative dose
• Registered with a social security system
• Patient having dated and signed an informed consent form before initiation of any study procedures

You may not qualify if:

• Respiratory pathology (SpO2\< 70 %)
• Severe undernutrition
• Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs
• Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID
• Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage
• Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified)
• Liver insufficiency
• Severe renal insufficiency
• Severe heart failure
• Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors
• Intolerance or hypersensitivity to one of the treatments or excipients
• Inability to swallow
• Pregnant or breastfeeding woman
• Patient under tutorship or guardianship

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Santelys Association: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Head and Neck Neoplasms; Agnosia

Interventions

Acetaminophen; Ketoprofen

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Danièle LEFEBVRE-KUNTZ, MD

  Centre Oscar Lambret

  STUDY DIRECTOR

• Nathalie LEROUX, MD

  Centre Oscar Lambret

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)